GWP - GDP

Compliance, Warehouse & Logistics

Compliance for Regulatory Purposes

For some clients, a warehouse compliance is required by legislative policy. For others, it forms part of a wider long-term strategy. And for some, it’s just about peace of mind.

Whatever your reasons, there are times when you simply must know what the regulations are before deciding where you’re headed.

Code of Good Wholesale Practice (GWP)

This Code is applicable to wholesalers who, for the purposes of this Code, are defined as persons or organisations, including manufacturers, wholesalers, manufacturer’s agents, importers and distributors who store and/or supply by wholesale substances and preparations (referred to in this document as “medicines”) included in Schedules 2, 3, 4 and 8 of the Standard for the Uniform Scheduling of Drugs and Poisons or other applicable State or Territory poisons legislation. The term “wholesaler” also includes providers of third party logistics and distribution.

Good Distribution Practice of medicinal products for human use. (GDP)

The Commission has published EU Guidelines on Good Distribution Practice (GDP) in 1994 ( 2 ). Revised guidelines were published in March 2013 ( 3 ) in order to take into account recent advances in practices for appropriate storage and distribution of medicinal products in the European Union, as well as new requirements introduced by Directive 2011/62/EU ( 4 ).

Therapeutic Goods (Medical Devices) Regulations 2009 update

Overview of the new regulatory framework for in vitro diagnostic medical devices (IVDs)

A new regulatory framework commenced on 1 July 2010 that ensures all IVDs will undergo a level of regulatory scrutiny that is commensurate with the risks associated with their use. The framework adopts the philosophies and recommendations of the Global Harmonization Task Force (GHTF) for IVDs, ensuring that requirements are internationally aligned.

Therapeutic Goods Act 1989

This compilation was prepared on 4 March 2005 taking into account amendments up to Act No. 8 of 2005. Prepared by the Office of Legislative Drafting and Publishing, Attorney-General's Department, Canberra

About Supply Today

We provide consultant services to companies that need operational excellence in their logistics, warehousing, inventory and processes. What we do is provide real hands-on experience and knowledge to meet those needs. Benefits are warehousing & logistics requirements are met, promises are fulfilled, compliance and accuracy is the result.